Cordis PRECISE Nitinol Stent System (5.5F and 6F)...2 1.0 Device Name The device brand name is the...

Instructions for UseCordis PRECISE® Nitinol Stent System (5.5F and 6F)

10368453-2

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1.0 Device NameThe device brand name is the Cordis PRECISE Nitinol StentSystem.

2.0 DescriptionThe Cordis PRECISE Nitinol Stent System consists of a nitinolself-expanding stent preloaded on a 5.5F (1.85 mm) or 6F(2.0 mm) sheathed delivery system. The delivery system consistsmainly of an inner shaft and an outer sheath with radiopaquemarkers, and a Tuohy Borst valve. The inner shaft terminatesdistally in a catheter tip and originates proximally in a Luer hubdesigned to accept a .018” (0.46 mm) guidewire. The deliverysystem has a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the spacebetween the inner shaft and the outer sheath, located betweendistal and proximal stent markers on the inner shaft. The stentexpands to its unconstrained diameter when released from thedeployment catheter into the carotid artery. Upon deployment,the stent forms an open lattice and pushes outward on theluminal surface, helping to maintain the patency of the artery.Due to the self-expanding behavior of nitinol, the stents areindicated for placement into vessels that are 1-2 mm smaller indiameter than the unconstrained diameter of the stent. Devicedepictions and their components are provided in Figures 1 and2, which follow.

Figure 15.5F (1.85 mm) Cordis PRECISE Nitinol Stent System

Figure 26F (2.0 mm) Cordis PRECISE Nitinol Stent System

1. Tuohy Borst valve2. Hypotube3. Coil4. Catheter inner shaft tip5. Luer hub6A. Proximal OD6B. Distal OD7. Outer sheath Luer hub8. Pod housing crimped stent9. Tuohy Borst Y-connection10. Proximal inner shaft marker (stop) marks trailing end

of stent11. Outer sheath radiopaque marker (BRITE TIP®)12. Proximal valve end13. Distal inner shaft stent marker14. Coil sleeve

The Cordis PRECISE Nitinol Stent System is provided as notedin Tables 1 and 2 below.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to seriousconsequences or injury to the patient.

STERILE. Cordis PRECISE® Nitinol Stent Systems are sterilized with ethylene oxide gas. Nonpyrogenic. Radiopaque.FOR ONE USE ONLY. DO NOT RESTERILIZE. Store in a cool, dark, dry place.

1. Tuohy Borst valve2. Hypotube3. Coil4. Catheter inner shaft tip5. Luer hub6A. Proximal OD6B. Distal OD7. Outer sheath Luer hub8. Pod housing crimped stent9. Tuohy Borst Y-connection10. Proximal inner shaft marker (stop) marks trailing end

of stent11. Outer sheath radiopaque marker (BRITE TIP®)12. Proximal valve end13. Distal inner shaft stent marker14. Coil sleeve

5.5F PRECISE® CATALOG UNCONSTRAINED STENTCODES DIMENSIONS

Diameter x Length (mm)

P05020XC 5 x 20

P05030XC 5 x 30

P05040XC 5 x 40

P06020XC 6 x 20

P06030XC 6 x 30

P06040XC 6 x 40

P07020XC 7 x 20

P07030XC 7 x 30

P07040XC 7 x 40

P08020XC 8 x 20

P08030XC 8 x 30

P08040XC 8 x 40

P68T30XC (Tapered) 8 proximal, 6 distal x 30 mm

TABLE 15.5F (1.85 mm) Cordis PRECISE® Nitinol Stent System

135 cm Working LengthGuidewire Lumen: Accepts .018” (0.46 mm) Guidewire

176A

9

12

6B

2 5

4 11 13 8 10 3 14

DETAIL "A"

176A

9

12

6B

2 5

4 11 13 8 10 3 14

DETAIL "A"

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3.0 Indications for UseThe Cordis PRECISE Nitinol Stent System used in conjunctionwith the ANGIOGUARDTM XP Emboli Capture Guidewire isindicated for the treatment of patients at high risk for adverseevents from carotid endarterectomy (see Section 8.2 of theseinstructions) who require carotid revascularization and meet thecriteria outlined below.

1. Patients with neurological symptoms and > 50% stenosis ofthe common or internal carotid artery by ultrasound orangiogram OR patients without neurological symptoms and> 80% stenosis of the common or internal carotid artery byultrasound or angiogram, AND

2. Patients must have a vessel diameter of 4-9 mm at the targetlesion. The vessel distal to the target lesion must be within therange of 3 mm and 7.5 mm to allow for placement of theANGIOGUARD XP Emboli Capture Guidewire.

4.0 ContraindicationsUse of the Cordis PRECISE Nitinol Stent System iscontraindicated in the following patients:1. Patients in whom antiplatelet and/or anticoagulation therapy is

contraindicated.2. Patients in whom the guide catheter is unable to be placed.3. Patients with uncorrected bleeding disorders.4. Patients with known allergies to nitinol.5. Lesions in the ostium of the common carotid artery.

5.0 Warnings5.1 General Warnings1. Only physicians who have received appropriate training for

carotid stenting and who are familiar with the principles,clinical applications, complications, side effects and hazardscommonly associated with carotid interventional proceduresshould use this device.

2. The safety and efficacy of the PRECISE Stent have not beendemonstrated with embolic protection systems other than theCordis ANGIOGUARD device.

3. The long-term performance (> 3 years) of carotid stents hasnot yet been established.

4. As with any type of vascular implant, infection secondary tocontamination of the stent may lead to thrombosis,pseudoaneurysm or rupture.

5. The stent may cause a thrombus, distal embolization or maymigrate from the site of implant down the arterial lumen.Appropriate sizing of the stent to the vessel is required toreduce the possibility of stent migration (see Section 9.3 ofthese instructions). In the event of thrombosis of theexpanded stent, thrombolysis and PTA should be attempted.

6. Overstretching of the artery may result in rupture and life-threatening bleeding.

7. In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oralabsorption of antiplatelet agents (e.g. aspirin) may beadversely affected.

8. The appropriate antiplatelet and anticoagulation therapyshould be administered pre- and post-procedure assuggested in Section 9.1 of these instructions.

9. In the event of complications such as infection,pseudoaneurysm or fistulization, surgical removal of the stentmay be required.

5.2 Patient Selection Warnings10.Safety and effectiveness of the Cordis PRECISE Nitinol Stent

System has NOT yet been established in patients with thecharacteristics noted below.

Lesion Characteristics:• Patients with evidence of intraluminal thrombus thought to

increase the risk of plaque fragmentation and distalembolization.

• Patients whose lesion(s) may require more than two stents.• Patients with total occlusion of the target vessel.• Patients with lesions of the ostium of the common carotid.• Patients with highly calcified lesions resistant to PTA.• Concurrent treatment of bilateral lesions.

Patient Characteristics:• Patients at low-to-moderate risk for adverse events from

carotid endarterectomy.• Patients experiencing acute ischemic neurologic stroke or

who experienced a stroke within 48 hours.• Patients with an intracranial mass lesion (i.e. abscess, tumor,

or infection) or aneurysm (> 9 mm).• Patients with arterio-venous malformations in the territory of

the target carotid artery.• Patients with coagulopathies.• Patients with poor renal function, who, in the physician’s

opinion, may be at high risk for a reaction to contrast medium.• Patients with perforated vessels evidenced by extravasation

of contrast media.• Patients with aneurysmal dilation immediately proximal or

distal to the lesion.• Pregnant patients or patients under the age of 18.

Access Characteristics:• Patients with known peripheral vascular, supra-aortic or

internal carotid artery tortuosity that would preclude the use ofcatheter-based techniques.

• Patients in whom femoral or brachial access is not possible.

11.Risk of distal embolization may be higher if the CordisPRECISE Nitinol Stent System cannot be used in conjunctionwith the ANGIOGUARD XP Emboli Capture Guidewire duringthe carotid stenting procedure.

5.3 Device Use Warnings12.The black dotted pattern on the gray temperature exposure

indicator found on the pouch must be clearly visible. Do notuse if entire circle is completely black as the pre-programmedstent diameter may have been compromised.

13.Do not use the device if there are abnormalities in the sterilebarrier (e.g. broken seal, torn or breached barrier) or product.

14.This device is intended for one-time use only. Do not re-sterilize and/or reuse. Structural integrity and/or function maybe impaired through reuse or cleaning.

15.Do not use the Cordis PRECISE Nitinol Stent System afterthe “Use By” date specified on the package.

16.Do not use with Ethiodol or Lipiodol* contrast media, whichmay adversely affect the stent delivery system.

17.Do not expose the delivery system to organic solvents (e.g.alcohol) as structural integrity and/or function of the devicemay be impaired.

18.The stent is not designed for dragging or repositioning.19.Once the stent is partially deployed, it cannot be recaptured

using the stent delivery system.20.As with any type of vascular implant, infection secondary to

contamination of the stent may lead to thrombosis,pseudoaneurysm or rupture.

6F PRECISE® CATALOG UNCONSTRAINED STENT CODES DIMENSIONS Diameter x Length (mm)

P09020XC 9 x 20

P09030XC 9 x 30

P09040XC 9 x 40

P10020XC 10 x 20

P10030XC 10 x 30

P10040XC 10 x 40



TABLE 26F (2.0 mm) Cordis PRECISE® Nitinol Stent System

135 cm Working LengthGuidewire Lumen: Accepts .018” (0.46 mm) Guidewire

* Ethiodol and Lipiodol are trademarks of Guerbet S.A.

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6.0 Precautions

6.1 Stent Handling Precautions1. The Cordis PRECISE® Nitinol Stent System is supplied

STERILE and is intended for single use only. DO NOTresterilize and/or reuse the device.

2. The 5.5F (1.85 mm) delivery system is shipped with theTuohy Borst valve in the OPEN position. The 6F (2.0 mm)delivery system is shipped with the Tuohy Borst valve in theLOCKED position. Care should be taken not to pre-deploy thestent. The device should be prepped in the tray. (See Section9.3, #2 of these instructions).

3. Do not use the Cordis PRECISE Nitinol Stent System afterthe “Use By” date specified on the package.

4. Do not use if the pouch is opened or damaged.5. Store in a cool, dark, dry place.

6.2 Stent Placement Precautions6. Venous access should be available during carotid stenting in

order to manage bradycardia and/or hypotension either bypharmaceutical intervention or placement of a temporarypacemaker, if needed.

7. When catheters are in the body, they should be manipulatedonly under fluoroscopy. Radiographic equipment that provideshigh quality images is needed.

8. The delivery system is not designed for the use of powerinjection. Use of power injection may adversely affect deviceperformance.

9. If resistance is met during delivery system introduction, thesystem should be withdrawn and another system used.

10.Prior to stent deployment, remove all slack from the catheterdelivery system (see Section 9.4, #4 of these instructions).

11.When treating multiple lesions, the distal lesion should beinitially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximalstent in placement of the distal stent and reduces the chancefor dislodging stents that have already been placed.

12.Overlap of sequential stents is necessary, but the amount ofoverlap should be kept to a minimum (approximately 5 mm).In no instance should more than 2 stents overlap.

6.3 Post Stent Placement Precautions13.Recrossing a deployed stent with adjunct devices must be

performed with caution.14. In the event of thrombosis of the expanded stent,

thrombolysis and PTA should be attempted.

6.4 MRI Safety and Compatibility15.The Cordis PRECISE Stent was evaluated through bench

testing and has been shown to be MR safe at field strengthsof 1.5 Tesla or less, with a maximum spatial gradient of3 T/m, gradient magnetic fields of 33 mT/m or less, atemporal magnetic field gradient (dB/dt) of 80 T/m/s, and amaximum whole body averaged specific absorption rate(SAR) of 1.33 W/kg for 16:40:00 min of MR imaging. MRimaging quality may be compromised if the area of interest isin the exact same area or relatively close to the position of thePRECISE Stent. The PRECISE Stent has not been evaluatedto determine if it is safe in MRI systems with field strengthsgreater than 1.5 Tesla.

7.0 Adverse Events

7.1 Observed Adverse EventsCarotid stenting with distal protection was conducted on a total of573 patients with carotid artery disease who were at high risk foradverse events from carotid endarterectomy (CEA) in theSAPPHIRE clinical study (Stenting and Angioplasty withProtection in Patients at High Risk for Endarterectomy). Thestudy was conducted to evaluate the safety and effectiveness ofthe Cordis PRECISE Nitinol Stent System and theANGIOGUARDTM XP Emboli Capture Guidewire.

The study included a randomized arm that compared stentpatients to CEA patients (334 patients). The study also includeda non-randomized stent arm for patients who met the same entrycriteria as the randomized patients, but who were determined bythe surgeon at the study site to be at too high a risk for adverseevents from CEA (406 patients). Patients meeting the sameinclusion criteria as the randomized patients, but determined bythe interventionalist to be inappropriate for stent treatment, wereentered into a non-randomized surgical arm (7 patients). Themajor adverse event (MAE) rate in all study arms was defined asdeath, stroke, or MI (Q-wave or non-Q-wave) to 30 days anddeath or ipsilateral stroke from 31 days to 360 days.

Only 7 patients were enrolled in the non-randomized surgical armof the SAPPHIRE study. The 360-day MAE rate for thesepatients was 14.3%. The MAE rates of the SAPPHIRERandomized Study arm (167 stent patients vs. 167 CEA patients)and the non-randomized stent arm (406 patients) are shown inTable 3, which follows.

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Table 3 - Randomized & Non-Randomized Patient Events

Randomized Stent Randomized CEA Non-Randomized30-Day Complications (N=167) (N=167) P-value* Stent (N=406)

MAE1 4.8% (8) 9.6% (16) 0.14 6.9% (28)

Death (All Cause) 1.2% (2) 2.4% (4) 0.68 2.2% (9)

Myocardial Infarction (Q or Non-Q) 2.4% (4) 6.0% (10) 0.17 1.7% (7)

Q Wave MI 0.0% (0) 1.2% (2) 0.50 0.2% (1)

Non-Q Wave MI 2.4% (4) 4.8% (8) 0.38 1.5% (6)

Stroke 3.6% (6) 3.0% (5) >0.99 4.9% (20)

Major Ipsilateral Stroke 0.6% (1) 1.2% (2) >0.99 2.5% (10)

Major Non-Ipsilateral Stroke 0.6% (1) 0.6% (1) >0.99 0.5% (2)

Minor Ipsilateral Stroke 2.4% (4) 0.6% (1) 0.37 1.7% (7)

Minor Non-Ipsilateral Stroke 0.6% (1) 0.6% (1) >0.99 0.5% (2)

Transient Ischemic Attack (TIA) 3.6% (6) 2.4% (4) 0.75 5.4% (22)

Target Lesion Revascularization 0.0% (0) 0.0% (0) - 0.5% (2)Surgery 0.0% (0) 0.0% (0) - 0.0% (0)PTA 0.0% (0) 0.0% (0) - 0.5% (2)

Target Vessel Revascularization(not involving Target Lesion) 0.0% (0) 0.0% (0) - 0.0%

Surgery 0.0% (0) 0.0% (0) - 0.0%PTA 0.0% (0) 0.0% (0) - 0.0%

Stent Thrombosis 0.0% (0) 0.0% (0) - 0.7% (3)

Major Bleeding2 9.0% (15) 10.2% (17) 0.85 12.8% (52)

Cranial Nerve Injury 0.0% (0) 4.2% (7) 0.01 0.0% (0)

Severe Hypotension 17.4% (29) 3.0% (5) <0.01 15.0% (61)

Bradycardia 8.4% (14) 3.0% (5) 0.06 3.2% (13)

Vascular Complications3 5.4% (9) N/A - 2.5% (10)

Device/Procedure Related Adverse Events4 0.0% (0) - - 0.0% (0)

31 to 360-Day Complications5 Randomized Stent Randomized CEA P-value* Non-Randomized(N=165)5 (N=163)5 Stent N=3975

MAE1 7.3% (12) 12.3% (20) 0.14 10.6% (42)

MAE without Non-Neurologic Deaths from31-360 days6 1.2% (2) 3.7% (6) 0.17 4.0% (16)

Death (All Cause) 6.1% (10) 10.4% (17) 0.16 8.1% (32)


Q Wave MI 0.0% (0) 0.0% (0) - 0.3% (1)

Non-Q Wave MI 0.6% (1) 1.8% (3) 0.37 0.8% (3)

Stroke 2.4% (4) 4.9% (8) 0.26 4.3% (17)

Major Ipsilateral Stroke 0.0% (0) 1.8% (3) 0.12 0.8% (3)

Major Non-Ipsilateral Stroke 0.0% (0) 0.6% (1) 0.50 0.8% (3)

Minor Ipsilateral Stroke 1.2% (2) 1.2% (2) >0.99 2.3% (9)

Minor Non-Ipsilateral Stroke 1.2% (2) 1.8% (3) 0.68 0.5% (2)


Target Lesion Revascularization 0.6% (1) 3.7% (6) 0.07 0.3% (1)Surgery 0.6% (1) 0.6% (1) >0.99 0.0% (0)PTA 0.0% (0) 3.1% (5) 0.03 0.3% (1)

Target Vessel Revascularization (not involvingTarget Lesion) 0.0% (0) 0.0% (0) - 0.0% (0)

Surgery 0.0% (0) 0.0% (0) - 0.0% (0)PTA 0.0% (0) 0.0% (0) - 0.0% (0)


Major Bleeding2 0.0% (0) 0.0%(0) - 0.5% (2)

Cranial Nerve Injury 0.0% (0) 0.6% (1) - 0.0% (0)

Severe Hypotension 0.6% (1) 0.0% (0) 0.99 0.8% (3)

Bradycardia 0.0% (0) 0.0% (0) - 0.3% (1)

Vascular Site Complications3 0.0% (0) N/A - 0.0% (0)

Device/Procedure Related Adverse Events4 0.0% (0) 0.0% (0) - 0.0% (0)

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* P-value displayed refers to comparison of randomized arms.(1) Major Adverse Events (MAE) = Death, MI or stroke to 30 days and death or ipsilateral stroke from 31-360 days.(2) Major Bleeding = Any non-access site-related bleeding resulting in a 25% or more decline in HCT or requiring transfusion.(3) Vascular Complications = Events related to bleeding or vascular injury at the percutaneous access site.(4) There were no device or procedure related events. In 17 of 19 initial stent delivery failures, a subsequent attempt was successful.

In one case, the patient was treated with CEA. In the other case, the patient was treated with balloon angioplasty alone. Onestent fracture was noted from one-year ultrasound films, with no adverse effect to the patient.

(5) Rates minus patient deaths to 30 days.(6) MAE without Non-Neurological Deaths >31 Days – The vast majority of deaths occurring from 31 days to 360 days were attributed

to the co-morbidities of this high-risk population. The 'adjusted' 360 day MAE rate includes all cause death, MI and all strokes today 30, and only neurologic deaths and ipsilateral strokes from days 31-360.

Table 3 (Continued) - Randomized Patient Events

Combined Complications to 360 Days Randomized Stent Randomized CEA Non-Randomized(N=167) (N=167) P-value* Stent (N=406)

MAE1 12.0% (20) 19.2% (32) 0.10 15.8% (64)

MAE without Non-Neurologic Deaths from31 days to 360 days6 6.0% (10) 12.6% (21) 0.06 10.3% (42)

Death (All Cause) 7.2% (12) 12.6% (21) 0.14 10.1% (41)


Q Wave MI 0.0% (0) 1.2% (2) 0.50 0.5% (2)

Non-Q Wave MI 3.0% (5) 6.0% (10) 0.29 2.2% (9)

Stroke 6.0% (10) 7.2% (12) 0.83 9.1% (37)

Major Ipsilateral Stroke 0.6% (1) 3.0% (5) 0.21 3.2% (13)

Major Non-Ipsilateral Stroke 0.6% (1) 1.2% (2) 1.00 1.2% (5)

Minor Ipsilateral Stroke 3.6% (6) 1.8% (3) 0.50 3.9% (16)

Minor Non-Ipsilateral Stroke 1.8% (3) 2.4% (4) 1.00 1.0% (4)


Target Lesion Revascularization 0.6% (1) 3.6% (6) 0.12 0.7% (3)Surgery 0.6% (1) 0.6% (1) 1.00 0.0% (0)PTA 0.0% (0) 3.0% (5) 0.06 0.7% (3)

Target Vessel Revascularization (not involvingTarget Lesion) 0.0% (0) 0.0% (0) - 0.0% (0)

Surgery 0.0% (0) 0.0% (0) - 0.0% (0)PTA 0.0% (0) 0.0% (0) - 0.0% (0)


Major Bleeding2 9.0% (15) 10.2% (17) 0.85 13.3% (54)

Cranial Nerve Injury 0.0% (0) 4.8% (8) 0.01 0.0% (0)

Severe Hypotension 17.4% (29) 3.0% (5) 0.00 15.5% (63)

Bradycardia 8.4% (14) 3.0% (5) 0.06 3.4% (14)

Vascular Complications3 5.4% (9) N/A - 2.5% (10)


Cause of Death Randomized Stent Randomized CEA Non-Randomized Stent

Neurologic 1 3 8

Cardiac 8 10 18

Respiratory Failure 1 3 4

Cancer 2 1 5

Renal Failure 0 1 1

Multi-System Failure 0 3 2

Exsanguination 0 0 1

Unknown 0 0 2

Table 3A - Causes of Death through 360 Days†

† None of the deaths were attributed to the device or the procedure.

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7.2 Potential Adverse EventsAdverse Events (in alphabetical order) that may be associatedwith the use of the Cordis PRECISE® Nitinol Stent System whenused in conjunction with the ANGIOGUARDTM XP EmboliCapture Guidewire include, but may not be limited to:• air embolism• allergic/anaphylactoid reaction• aneurysm• angina/coronary ischemia• arrhythmia (including bradycardia, possibly requiring need for

a temporary or permanent pacemaker)• arterial occlusion/restenosis of the treated vessel• arterial occlusion/thrombus, at puncture site• arterial occlusion/thrombus, remote from puncture site• arteriovenous fistula• bacteremia or septicemia• cerebral edema• damage to emboli capture device• death• embolization, arterial• embolization, stent• emergent repeat hospital intervention• fever• GI bleeding from anticoagulation/antiplatelet medication• hematoma bleed, puncture site• hematoma bleed, remote site• hemorrhage• hyperperfusion syndrome• hypotension/hypertension• infection• intimal injury/dissection• ischemia/infarction of tissue/organ• local infection and pain at insertion site• malposition (failure to deliver the stent to the intended site)• myocardial infarction• pain• pseudoaneurysm• renal failure• restenosis of the vessel (> 50% obstruction)• seizure• severe unilateral headache• stent migration• stent thrombosis• stroke• transient ischemic attack• vasospasm• venous occlusion/thrombosis, at puncture site• venous occlusion/thrombosis, remote from puncture site• vessel rupture, dissection, perforation

7.3 Device Related Adverse Event ReportingAny adverse event (clinical incident) involving the CordisPRECISE Nitinol Stent System should be reported to CordisCorporation immediately. To report an incident, call the ProductQuality Services Department at 1-800-327-7714, option 4.

8.0 Clinical Study Information

8.1 ObjectivesThe primary objective of the pivotal clinical study (SAPPHIRE)was to compare the safety and effectiveness of the CordisPRECISE Nitinol Stent Systems, used in conjunction with theANGIOGUARD XP Emboli Capture Guidewire, to carotidendarterectomy (CEA) in the treatment of carotid artery diseasein patients at increased risk for adverse events from CEA. Studyhypotheses examined whether the major adverse events (MAE)rate of randomized stent patients was not inferior to randomizedCEA patients. Safety evaluations included assessments of majorclinical events occurring during the procedure, prior to discharge,within 30 days, six months, one year and every 12 monthsthereafter for a total of three years; access site vascularcomplications; independent neurological assessments at 24hours, 30 days, six months and one year post-procedure.Effectiveness evaluations included assessments of successfulstent deployment at the target lesion; less than 30% residualdiameter stenosis at the completion of the procedure asmeasured by carotid angiography; and restenosis (> 50%) asdetermined by carotid ultrasound at 30 days, six months and oneyear post-procedure and every 12 months thereafter for a total ofthree years.

8.2 Study DesignThe pivotal SAPPHIRE study was a multi-center, prospective,randomized, triangular sequential trial comparing patients atincreased risk for adverse events from CEA who received a stentto a surgical (CEA) control. The safety and effectiveness of theCordis PRECISE Nitinol Stent System, used in conjunction withthe ANGIOGUARD XP Emboli Capture Guidewire in thetreatment of de novo or restenotic obstructive carotid arterydisease in these patients was evaluated.

The study also included a non-randomized stent arm, whichincluded those patients who met entry criteria but who weredetermined by the surgeon at the study site to be at too high arisk for adverse outcomes from surgery and thereforeinappropriate for randomization. Likewise, patients meeting theentry criteria, but determined by the interventionalist to beunacceptable candidates for stenting and therefore notrandomizable, had the option of entering a non-randomizedsurgical arm.

SAPPHIRE entry criteria were identical for all patients. Allpatients were evaluated to determine whether they met the entrycriteria by a multi-disciplinary team consisting of a neurologist,interventionalist, and vascular surgeon. Patients meeting thecriteria were either randomized to treatment by stent or CEA, orplaced into the non-randomized stent or CEA arms, based on themedical judgment of the interventionalist and surgeon as notedabove. Patients who were entered into this study were eitherasymptomatic with a > 80% diameter stenosis or symptomaticwith a > 50% diameter stenosis. Symptomatic patients weredefined as those patients who have one or more TIAs,characterized by distinct focal neurological dysfunction ormonocular blindness with clearing of signs and symptoms within24 hours or one or more completed strokes with persistence ofsymptoms or signs for more than 24 hours. In addition, ALLpatients must also have had at least one anatomic or co-morbidrisk factor placing them at high-risk for adverse events from CEA.These risk factors are as follows:• Congestive Heart Failure (Class III/IV), and/or known severe

left ventricular dysfunction < 30%• Open-heart surgery within 6 weeks• Recent myocardial infarction (>24 hours and <4 weeks)• Unstable angina (CCS class III/IV)• Synchronous severe cardiac and carotid disease requiring

open heart surgery and carotid revascularization• Severe pulmonary disease to include any of the following:

- Chronic oxygen therapy- Resting P02 of < 60 mmHg- Baseline hematocrit > 50%- FEV1 or DLCO < 50% of normal

• Contralateral carotid occlusion• Contralateral laryngeal palsy• Post-radiation treatment• Previous CEA recurrent stenosis• High cervical ICA lesions• CCA lesions below the clavicle• Severe tandem lesions• Abnormal stress test

The primary endpoint was a composite of MAE including death,any stroke, or myocardial infarction (MI), in the first 30 daysfollowing treatment and death or ipsilateral stroke between 31days and 12 months. An independent Clinical Events Committeeadjudicated all MAE’s and other events. Endpoints wereanalyzed on an intent-to-treat basis.

A total of 747 patients were enrolled in the SAPPHIRE study at29 centers in the United States. The randomized populationincluded 334 patients (167 stent/167 CEA), 310 of who weretreated per protocol. The primary reasons why the remaining 24patients were not treated were: 1) Eleven patients withdrewconsent; 2) Six patients were found not to meet inclusion criteriasubsequent to randomization; 3) Five patients’ conditionsdeteriorated and they became too high a risk for any treatment;and 4) Two patients were randomized to surgery that was neverperformed. The non-randomized stent arm included 406 patientsand the non-randomized CEA arm included seven patients.

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reviewed ultrasound and angiographic films. A third independentlaboratory analyzed trapped material contained in a percentageof all ANGIOGUARDTM XP filter baskets. A Clinical EventsCommittee (CEC) adjudicated all clinical events and anindependent Data Safety Monitoring Board (DSMB) monitoredsafety.

8.3 Patient DemographicsTable 5 provides the subject characteristics of randomized patients and non-randomized stent patients enrolled in the SAPPHIRE trial.

0 days 30 days 360 days

# Patients Alive at Time Interval• Randomized stent 167 165 (99.0%) 155 (93.0%)• Randomized CEA 167 163 (98.0%) 146 (87.4%)• Non-randomized stent 406 397 (98.1%) 365 (90.0%)

Clinical Evaluation• Randomized stent 167 (100%) 158 (96.0%) 145 (94.0%)• Randomized CEA 167 (100%) 145 (89.1%) 125 (86.0%)• Non-randomized stent 406 (100%) 389 (98.1%) 342 (94.1%)

Angiographic Evaluation (Core Lab)• Randomized stent 149 (89.2%) N/A N/A• Randomized CEA N/A N/A N/A• Non-randomized stent 386 (95.1%) N/A N/A

Ultrasound Evaluation (Core Lab)• Randomized stent 142 (85.0%) N/A 125 (81.0%)• Randomized CEA 141 (84.4%) N/A 101 (69.2%)• Non-randomized stent 341 (84.0%) N/A 287 (79.0%)

Neurological Evaluation• Randomized stent 165 (99.0%) 148 (90.0%) 126 (81.3%)• Randomized CEA 155 (93.0%) 131 (80.4%) 96 (66.1%)• Non-randomized stent 398 (98.0%) 361 (91.0%) 293 (80.3%)

Table 4 - SAPPHIRE Patient Follow-Up and Accountability

Table 5 - SAPPHIRE Patient Demographics*

Non-RandomizedPatient Characteristics Randomized Stent Randomized CEA P-value** Stent

Age (Years) 72.5 + 8.3 72.3 + 9.1 0.86 71.4 + 9.8% Male 66.9% (111/166) 67.1% (108/161) 1.00 64.3% (261/406)Diabetes 25.3% (42/166) 27.5% (44/160) 0.71 30.8% (125/406)Coronary Artery Disease 85.8% (133/155) 75.5% (111/147) 0.03 68.9% (259/376)Previous PTCA (Coronary) 34.8% (56/161) 23.4% (37/158) 0.03 21.2% (83/392)Previous CABG 43.4% (72/166) 30.8% (49/159) 0.02 31.5% (128/406)Previous Q-Wave or Non Q-Wave MI 29.7% (46/155) 35.3% (54/153) 0.33 33.4% (122/365)Angina at a Low Workload or Unstable Angina 24.1% (20/83) 14.7% (11/75) 0.16 31.5% (41/130)Congestive Heart Failure 17.5% (29/166) 17.4% (28/161) 1.00 18.2% (74/406)Coexistent Severe Coronary Artery Disease 15.9% (26/164) 16.5% (26/158) 1.00 12.8% (51/400)Requiring Carotid and Coronary RevascularizationSystolic Blood Pressure 151.7 + 26.0 153.5 + 26.9 0.54 148.2 + 27.2History of Dyslipidemia 78.5% (128/163) 76.9% (123/160) 0.79 73.9% (289/391)Previous CEA/Recurrent Stenosis 22.6% (37/164) 22.2% (35/158) 1.00 37.7% (151/401)Post-Radiation Treatment 4.3% (7/164) 5.7% (9/158) 0.61 16.2% (64/401)Prior CEA 28.3% (47/166) 26.7% (43/161) 0.80 45.2% (183/405)Contralateral Carotid Occlusion 23.6% (39/165) 25.3% (40/158) 0.80 16.3% (65/400)History of Stroke 27.1% (45/166) 23.8% (38/160) 0.53 32.3% (129/399)History of TIA 31.1% (50/161) 34.0% (53/156) 0.63 34.5% (138/400)High Cervical ICA Lesions 4.3% (7/164) 4.4% (7/158) 1.00 12.7% (51/401)CCA Lesions Below the Clavicle 0.0% (0/164) 0.0% (0/158) - 3.0% (12/401)Other Co-morbid Risk Factors Precluding CEA 0.0% (0/164) 0.0% (0/160) - 7.9% (32/404)Renal Insufficiency 6.0% (10/166) 7.5% (12/160) 0.66 7.4% (30/405)Current Cigarette Use 16.9% (27/160) 16.4% (26/159) 1.00 13.5% (54/399)Patients >80 years 19.3% (32/166) 20.5% (33/161) 0.78 19.2% (78/406)

* The denominator represents the total number of responses to a question in the case report form.**P-value displayed refers to comparison of randomized arms.

Follow-up evaluations were scheduled at 30 days, six monthsand one-year post procedure, and annually thereafter for threeyears. Patient follow-up and accountability at 30 days and 360days are presented in Table 4, as these were the primary dataanalysis time points.

Imaging data provided in this summary are based on findingsfrom two independent centralized Core Laboratories, which

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A comparison of the non-randomized stent arm and therandomized CEA arm was conducted utilizing a propensity scoreanalysis that accounted for baseline imbalances due to the non-randomized (i.e., more observational) nature of groupmembership. The analysis found the treatment difference (non-randomized stent minus CEA) in 360-day MAE was –5.3%, withan adjusted 95% confidence interval of –13.4% to 3.0%. Thus,after adjusting for the higher risk of patients in the non-randomized stent arm, 360-day MAE outcomes were non-inferiorto the CEA arm of the randomized study within a 3% delta.

Principal safety and effectiveness results to 360 days arepresented in Table 6, which follows. The cumulative percentageof MAE through 360 days for the randomized and non-randomized stent patients is presented in Figure 3, whichfollows. Non-randomized CEA patient event rates are notprovided in Table 6 since only seven patients were enrolled inthat study arm and the data are insufficient for statistical analysis.For informational purposes, the MAE rate for non-randomizedCEA patients to 360 days was 14.3% (1/7). Figures 4 and 5present the cumulative percentage of MAE through 360 days forrandomized asymptomatic and symptomatic patients.

8.4 Study ResultsThe 360-day major adverse events (MAE) rate, defined as death,stroke, or MI (Q-wave or non-Q-wave) to 30 days and death oripsilateral stroke from 31 days to 360 days was 12.0% for therandomized stent patients compared with 19.2% for the controlgroup. These results demonstrate non-inferiority (p=0.004) ofcarotid stenting to carotid endarterectomy (CEA) with the pre-specified non-inferiority delta of 3%.

The MAE rate at 360 days for the non-randomized stent patientswas 15.8%. In a test of the primary endpoint against theObjective Performance Criteria (OPC), despite the fact that therate was numerically less than the OPC plus the delta, the p-value was found to be 0.2899. In a test of the MAE rate whenpost 30-day non-neurological deaths are not included, the p-value was found to be <0.0001. The causes of these non-neurological deaths are well documented, and consist of cardiacdeaths, cancer deaths, renal failure, and respiratory failure.

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Numbers are % (counts/sample size).*P-value displayed refers to comparison of randomized arms.**Cumulative percentage estimates are by Kaplan-Meier methods with standard error estimates by Peto formula.(1) Major Adverse Events (MAE) = Death, MI or stroke to 30 days and death or ipsilateral stroke from 31-360 days.(2) Major Bleeding = Any non-access site related bleeding resulting in a 25% or more decline in HCT or requiring transfusion.(3) Vascular Complications = Events related to bleeding or vascular injury at the percutaneous access site.(4) There were no device or procedure related events. In 17 of 19 initial stent delivery failures, a subsequent attempt was successful.

In one case, the patient was treated with CEA. In the other case, the patient was treated with balloon angioplasty alone. One stentfracture was noted from one-year ultrasound films, with no adverse effect to the patient.

(5) Lesion Success = The attainment of a final residual stenosis of <30% using any percutaneous method. If no in-stent measurementswere available, in-lesion measurements were used, and if no QCA was available, visual estimates were used.

(6) Procedure Success = The attainment of a final residual stenosis of <30% and no in-hospital MAE. If no in-stent measurementswere available, in-lesion measurements were used, and if no QCA was available, visual estimates were used.

(7) Device Success = The attainment of a final residual stenosis of <30% using only the assigned device. If no in-stent measurementswere available, in-lesion measurements were used, and if no QCA was available, visual estimates were used.

(8) ANGIOGUARDTM Success = Successful deployment and retrieval of the ANGIOGUARDTM device.(9) In-lesion % DS Measurement = Defined as the % diameter stenosis either within the stented segment or within 5mm

proximal or distal to the stent edges.(10) In-stent % DS Measurement = Defined as the % diameter stenosis within the stented segment.(11) Binary Restenosis is defined by Ultrasound as % diameter stenosis >50%.(12) TLR = Target Lesion Revascularization

Table 6 - Principal Safety & Effectiveness Results To 360 Days (Intent to Treat)

Safety Measures & Other Clinical Events Randomized Stent Randomized CEA P-value* Non-Randomizedto 360 Days (N=167) (N=167) Stent (N=406)

MAE1 12.0% (20/167) 19.2%(32/167) 0.10 15.8% (64/406)

Death (All Cause) 7.2% (12/167) 12.6% (21/167) 0.14 10.1% (41/406)

Stroke 6.0% (10/167) 7.2% (12/167) 0.83 9.1% (37/406)

Major Ipsilateral Stroke 0.6% (1/167) 3.0%(5/167) 0.21 3.2% (13/406)

Minor Ipsilateral Stroke 3.6% (6/167) 1.8% (3/167) 0.50 3.9% (16/406)

Myocardial Infarction (Q or Non-Q) 3.0% (5/167) 7.2% (12/167) 0.13 2.7% (11/406)

TIA 6.6% (11/167) 3.0% (5/167) 0.20 6.9% (28/406)

Major Bleeding2 9.0% (15/167) 10.2% (17/167) 0.85 13.3% (54/406)

Cranial Nerve Injury 0.0% (0/167) 4.8% (8/167) 0.01 0.0% (0/406)

Severe Hypotension 17.4% (29/167) 3.0% (5/167) <0.01 15.5% (63/406)

Bradycardia 8.4% (14/167) 3.0% (5/167) 0.06 3.4% (14/406)

Vascular Complications3 5.4% (9/167) N/A - 2.5% (10/406)


Efficacy Measures Randomized Randomized P-Value* Non-RandomizedStent (N=167) CEA (N=167) Stent (N=406)

Lesion Success 5 91.8% (145/158) N/A N/A 90.4% (368/407)

Procedure Success 6 88.1% (140/159) N/A N/A 87.9% (355/404)

Device Success7 91.2% (145/159) N/A N/A 89.6% (363/405)

ANGIOGUARDTM Success8 95.6% (152/159) N/A N/A 91.6% (372/406)

Post-Procedure In-Lesion Minimal LumenDiameter (MLD in mm)

Mean+SD (N) 3.9+0.8 (147) 3.8+0.8 (385)Range (min, max) (2.1,7.3) N/A N/A (2.0, 8.1)

Post-Procedure In-Lesion Percent DiameterStenosis (%DS)9

Mean+SD (N) 17.2+11.3(147) 18.5+ 12.6 (385)Range (min, max) (1.5, 49.3) N/A N/A (-12.1, 64.7)

Post-Procedure In-Stent Minimal LumenDiameter (MLD in mm)

Mean+SD (N) 4.3+0.9 (147) 4.1+0.8 (381)Range (min, max) (2.1, 7.9) N/A N/A (2.2, 8.1)

Post-Procedure In-Stent Percent DiameterStenosis (%DS)10

Mean+SD (N) 8.3+16.7 (147) 10.9+14.2 (381)Range (min, max) (-42.0, 46.6) N/A N/A (-34.9, 43.8)

Binary Ultrasound In-Vessel Restenosis at 360 days11 19.7% (24/122) 31.3% (30/96) 0.06 27.7% (78/282)Binary Ultrasound In-Stent Restenosis at 360 days11 15.6% (19/122) 13.5% (13/96) 0.70 18.4% (52/282)Cumulative % of TLR at 360 days**12 0.6% 4.3% 0.04 0.8%Cumulative % of MAE1 at 360 days** 12.2% 20.1% 0.05 16.0%

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Time After Procedure (Days) – Randomized Patients

0 30 180 360Stent

N at risk 167 158 152 143 % with events 1.8 4.2 7.9 12.2

CEAN at risk 167 146 136 118% with events 0.6 9.8 15.5 20.1

Test Between GroupsLog-Rank P-Values 0.053

Time After Procedure (Days) – Non-Randomized Patients

0 30 180 360Stent

N at risk 406 382 352 329% with events 1.5 6.9 12.2 16.0

* Major Adverse Events (MAE) = Death, MI or stroke to 30 days and death or ipsilateral stroke from 31-360 days.

Time After Procedure (Days)

0 30 360Stent

N at Risk 117 109 100 % with Events 2.6 6.0 10.5

CEAN at Risk 119 103 84% with Events 0.8 9.4 20.3

Test Between GroupsLog-Rank P-Values 0.044


Figure 4Cumulative Percentage of MAE* at 360 days – Asymptomatic Randomized Stent and CEA Patients

Figure 3Cumulative Percentage of MAE* at 360 days

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Figure 5Cumulative Percentage of MAE* at 360 Days – Symptomatic Randomized Stent & CEA Patients

Time After Procedure (Days)

0 30 360Stent

N at risk 50 49 42 % with events 0.0 2.0 16.3

CEAN at risk 46 42 32% with events 0.0 10.9 20.0

Test Between GroupsLog-Rank P-value 0.582


9.0 Directions for UseOnly physicians who have received appropriate training forcarotid stenting and who are familiar with the principles, clinicalapplications, complications, side effects and hazards commonlyassociated with carotid interventional procedures should use thisdevice.

9.1 Peri-Procedural CareSAPPHIRE study patients were started on aspirin 81-325 mgdaily, 72 hours prior to the procedure and continued indefinitelyafter the procedure unless the patient had an allergy to it or couldnot tolerate it. Another oral anti-platelet agent, such as ticlopidine(250 mg b.i.d.) or clopidogrel (75 mg q.d.), was given pre-procedure (beginning at least 24 hours prior to the procedure, but48 hours was recommended) and continued after the procedurefor two weeks. If clopidogrel was used, a 300 mg dose was alsogiven post-stent deployment. If a second oral antiplatelet agentwas not given prior to the procedure, then a loading dose such asclopidogrel 300 mg was given immediately post-stent-deploymentand continued at the usual daily dose for two weeks. Ifclopidogrel 75 mg q.d. was administered for at least two daysprior to the stent procedure, the 300 mg dose was not necessary.

In addition to usual care and the suggested peri-procedurepharmacological regimen, special attention to diagnosis andmanagement of the following conditions are critical for optimalpatient care:• Bradycardia/tachycardia• Hypertension or hypotension• Acute and subacute stent thrombosis• Hyperperfusion syndrome

9.2 Pre-procedureRefer to Section 9.1 of these instructions for the suggested pre-procedure pharmacological treatment regimen. Thepercutaneous placement of the stent in a stenotic or obstructedcarotid artery should be done in an angiography procedure room.Angiography should be performed to map out the extent of thelesion(s) and the collateral flow. If thrombus is present, do notproceed with stent deployment. Access vessels must besufficiently patent or sufficiently recanalized, to proceed withfurther intervention. Patient preparation and sterile precautionsshould be the same as for any angioplasty procedure.

CAUTION: Venous access should be available during carotidstenting in order to manage bradycardia and/or hypotensioneither by pharmaceutical intervention or placement of atemporary pacemaker if needed.

CAUTION: When catheters are in the body, they should bemanipulated only under fluoroscopy. Radiographic equipmentthat provides high quality images is needed.

a) Inject contrast media – Perform an angiogram usingstandard technique.

b) Identify and mark the lesion – Fluoroscopically identify andmark the lesion, observing the most distal level of thestenosis.

9.3 Device Selection and Preparation1. Select Stent SizeMeasure the length of the target lesion to determine the length ofstent(s) required. When more than one stent is required to coverthe lesion, the more distal stent should be placed first. Overlap ofsequential stents is necessary, but the amount of overlap shouldbe kept to a minimum (approximately 5 mm).

Measure the diameter of the reference vessel (proximal anddistal to the lesion). It is necessary to select a stent which has anunconstrained diameter that is 1 to 2 mm larger than the largestreference vessel diameter to achieve secure placementaccording to the following Stent Size Selection Table (Table 7).

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† Ethiodol and Lipiodol are trademarks of Guerbet S.A.

Table 7Stent Size Selection Table

Straight Stent Sizes - 20, 30, & 40 mm lengthsTapered Stents - 30 mm length

5.5F (1.85 mm) Delivery System

Vessel Lumen Unconstrained % LengthDiameter Stent Diameter Foreshortening*

3.0-4.0 mm 5.0 mm 1.2%4.0-5.0 mm 6.0 mm 2.4%5.0-6.0 mm 7.0 mm 4.1%6.0-7.0 mm 8.0 mm 6.2%4 – 5 mm distal 6 mm distal 4.1%6 – 7 mm proximal 8 mm proximal(Tapered Vessel) (Tapered Vessel)

6F (2.0 mm) Delivery System

7.0-8.0 mm 9.0 mm 5.8%8.0-9.0 mm 10.0 mm 8.0%5 – 6 mm distal 7 mm distal 4.1%7 – 8 mm proximal 9 mm proximal(Tapered Vessel) (Tapered Stent)5 – 6 mm distal 7 mm distal 4.8%8 – 9 mm proximal 10 mm proximal(Tapered Vessel) (Tapered Stent)

* Mathematical calculation.

Use of Tapered Stents:The PRECISE® 6-8 mm x 30 mm, 7-9 x 30 mm and 7-10 x 30mm tapered stents are specifically designed to stent lesions at ornear the carotid bifurcation when trying to avoid over-sizing in theinternal carotid by more than 1-2 mm as a result of vesselmismatch (>1 mm) between the common and internal carotidarteries. Placement of the distal end of the stent should be highenough above the disease such that the distal end of the stent isplaced well within the healthy portion of the internal carotid (seeFigure A, which follows). Placement as shown in Figure B isnot recommended.

The distal end of the stent (6 or 7 mm) should be oversized 1-2mm to the reference vessel in the internal carotid. Likewise theproximal end of the stent (8, 9 or 10 mm) should be oversized 1-2 mm to the reference vessel in the common carotid. See FigureA, which follows.

Placement of a Tapered Stent

2. Preparation of Stent Delivery System.

CAUTION: The Cordis PRECISE Nitinol Stent System issupplied STERILE and is intended for single use only. DO NOTresterilize and/or reuse the device. Assure that the device hadbeen properly stored in a cool, dark, dry place prior to use.

CAUTION: Use the Cordis PRECISE Nitinol Stent System priorto the “Use By” date specified on the package. Do not use if thepouch is opened or damaged.

CAUTION: The 5.5F (1.85 mm) and 6F (2.0 mm)CordisPRECISE Nitinol Stent Systems are shipped with the TuohyBorst valve in different positions. The 5.5F (1.85 mm) stentdelivery system is shipped with the Tuohy Borst valve in theOPEN position, and the 6F (2.0 mm) stent delivery system isshipped with the Tuohy Borst valve in the LOCKED position. Becareful not to prematurely deploy the stent during preparation.The systems should be prepped in the sterile tray per theinstructions below. For the 5.5F (1.85 mm) system, close theTuohy Borst valve prior to removing the device from the tray. Forthe 6F (2.0 mm) system, ensure the Tuohy Borst valve is closedprior to removing the device from the tray.

a) Open the outer box to reveal the pouch containing the stentand delivery system.

b) Check the temperature exposure indicator on the pouch toconfirm that the black dotted pattern with a gray backgroundis clearly visible. Do not use if entire temperature exposureindicator is completely black as the unconstrained stentdiameter may have been compromised.

c) After careful inspection of the pouch looking for damage to thesterile barrier, carefully peel the pouch open and remove thetray. Examine the device for any damage. If it is suspectedthat the sterility or performance of the device has beencompromised, the device should not be used.

d) With the device in the tray, unlock the Tuohy Borst valve.(NOTE: This is only necessary for the 6F (2.0 mm)PRECISE® device as the Tuohy Borst valve on the 5.5F(1.85 mm) PRECISE® device is shipped in the open position.)

e) While in the tray, attach a stopcock to the Y connection on theTuohy Borst valve.

f) With the device still in the tray, attach a 3-cc syringe filled withheparinized saline to the open stopcock and apply positivepressure until heparinized saline weeps from the back end ofthe Tuohy Borst valve. Lock the Tuohy Borst valve. Whileviewing the distal end of the catheter, flush again untilheparinized saline weeps from the distal catheter end.

g) Close the stopcock attached to the Tuohy Borst Y connection.h) Extract the stent delivery system from the tray. Examine the

device for any damage. Evaluate the distal end of thecatheter to ensure that the stent is contained within the outersheath. Do not use if the stent is partially deployed. If a gapbetween the catheter tip and outer sheath tip exists, open theTuohy Borst valve and gently pull the inner shaft in a proximaldirection until the gap is closed. Lock the Tuohy Borst valveafter the adjustment by rotating the proximal valve end in aclockwise direction.

9.4 Stent Deployment Procedure

WARNING: Do not use with Ethiodol or Lipiodol† contrast media,which may adversely affect the stent delivery system.

WARNING: Do not expose the delivery system to organicsolvents (alcohol), as structural integrity and/or function of thedevice may be impaired.

CAUTION: The delivery system is not designed for the use ofpower injection. Use of power injection may adversely affectdevice performance.

1. Insertion of Introducer Sheath or Guiding Catheter andCordis ANGIOGUARDTM XP Emboli Capture Guidewirea) Access the treatment site utilizing the appropriate accessory

equipment compatible with a 5.5F (1.85 mm) or 6F (2.0 mm)stent delivery system.

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b) Insert and deploy the ANGIOGUARDTM XP Emboli CaptureGuidewire System via the introducer sheath or guidingcatheter in accordance with the Cordis ANGIOGUARD XPEmboli Capture Guidewire Instructions for Use. Refer tothe ANGIOGUARD XP Emboli Capture GuidewireInstructions for Use for detailed placement procedureand use of that device.

c) The Cordis PRECISE® Nitinol Stent System is compatible witha .018" (0.46 mm) or smaller guidewire.

2. Dilation of Lesiona) Pre-dilate the lesion using standard PTA techniques.b) Remove the PTA balloon catheter from the patient

maintaining lesion access with the guidewire.

3. Introduction of Stent Delivery Systema) Flush the guidewire lumen of the stent delivery system with

heparinized saline utilizing a 10-cc syringe to expel air.b) Ensure that the Tuohy Borst valve connecting the inner shaft

and outer sheath is locked by rotating the proximal valve endin a clockwise direction to prevent premature stentdeployment.

c) Advance the device over the ANGIOGUARD XP EmboliCapture Guidewire system to the lesion site.

CAUTION: If resistance is met during stent delivery systemintroduction, the stent delivery system should be withdrawn andanother system should be used, while the ANGIOGUARD XPEmboli Capture Guidewire remains in place.

4. Slack Removala) Advance the stent delivery system past the lesion site.b) Pull back the stent delivery system until the radiopaque inner

shaft markers (leading and trailing ends) move in position sothat they are proximal and distal to the target lesion.

c) Ensure the device outside the patient remains flat andstraight.

CAUTION: Prior to stent deployment, remove all slack from thecatheter delivery system. Slack in the catheter shaft eitheroutside or inside the patient may result in deployment of the stentbeyond the lesion site.

5. Stent Deployment

WARNING: The stent is not designed for dragging orrepositioning. Once the stent is partially deployed, it cannot berecaptured using the stent delivery system.

The mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft positionwhile retracting the outer sheath and allowing the stent toexpand.

NOTE: It is recommended that heparin (intravenous) be givenduring the procedure immediately after guiding cathetercannulation. The initial bolus dose of heparin should beapproximately 3,000 to 5,000 units (with necessary weightadjustments). Additional bolus doses of heparin should be givento maintain an ACT near 300 seconds during the entireprocedure. No heparin should be given after the procedure untilhemostasis at the puncture site is achieved.

a) Verify that the delivery system’s radiopaque inner shaftmarkers (leading and trailing ends) are proximal and distal tothe target lesion.

b) Unlock the Tuohy Borst valve connecting the inner shaft andouter sheath of the delivery system.

c) Ensure that the access sheath or guiding catheter does notmove during deployment.

d) Initiate stent deployment by retracting the outer sheath whileholding the inner shaft in a fixed position. Deployment iscomplete when the outer sheath marker passes the proximalinner shaft stent marker.

CAUTION: When more than one stent is required to cover thelesion, or if there are multiple lesions, the more distal stentshould be placed first. Stenting in this order obviates the need tocross the proximal stent in placement of the distal stent andreduces the chance for dislodging stents that have already beenplaced.

CAUTION: Overlap of sequential stents is necessary but theamount of overlap should be kept to a minimum (approximately5 mm). In no instance, should more than two (2) stents everoverlap.

6. Post-deployment Stent DilatationCAUTION: The delivery system is not designed for the use ofpower injection. Use of power injection may adversely affectdevice performance.

CAUTION: Re-crossing a deployed stent with adjunct devicesmust be performed with caution.

a) While using fluoroscopy, withdraw the entire delivery systemas one unit, over the guidewire and out of the body. Removethe delivery device from the guidewire. NOTE: If anyresistance is met during delivery system withdrawal, advancethe outer sheath until the outer sheath marker contacts thecatheter tip and withdraw the system as one unit. (Do notremove guidewire.)

b) Using fluoroscopy, visualize the stent to verify fulldeployment.

c) If incomplete expansion exists within the stent at any pointalong the lesion, post-deployment balloon dilatation (standardPTA technique) can be performed.

d) Select an appropriate size PTA balloon catheter and dilate thelesion with conventional technique. The inflation diameter ofthe PTA balloon used for post-dilatation should approximatethe diameter of the reference vessel. Remove the PTAballoon from the patient.

7. Post Stent Placementa) A post stent angiogram should be obtained.b) Remove the ANGIOGUARD XP Emboli Capture Guidewire

system in accordance with that device’s Instructions forUse. Remove the sheath and compress the puncture site toachieve hemostasis.

c) Discard the delivery system, guidewire, and sheath.d) Follow the suggested post-procedure pharmacological

treatment regimen described in Section 9.1 of theseinstructions.

WARNING: In the event of thrombosis of the expanded stent,thrombolysis and PTA should be attempted.

WARNING: In the event of complications such as infection,pseudoaneurysm or fistulization, surgical removal of the stentmay be required.

10.0 Patient InformationIn addition to these Instructions for Use, the Cordis PRECISENitinol Stent System is packaged with a Stent Implant Card forthe patient that contains specific information about the CordisPRECISE Nitinol Stent System. All patients should be instructedto keep this card in their possession at all times for procedure/stent identification.

A Patient Brochure, which includes information on carotid arterydisease, the carotid stent implant procedure, and the CordisPRECISE Nitinol Stent System is available from Cordis and canbe obtained by accessing www.cordislabeling.com or bycontacting Cordis at 1-800-327-7714.

11.0 How SuppliedThe Cordis PRECISE Nitinol Stent System is supplied sterile (byethylene oxide gas) and is intended for ONE USE ONLY.

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DISCLAIMER OF WARRANTY AND LIMITATION OFREMEDY

THERE IS NO EXPRESS OR IMPLIED WARRANTY,INCLUDING WITHOUT LIMITATION ANY IMPLIEDWARRANTY OF MERCHANTABILITY OR FITNESS FOR APARTICULAR PURPOSE, ON THE CORDIS PRODUCT(S)DESCRIBED IN THIS PUBLICATION. UNDER NOCIRCUMSTANCES SHALL CORDIS BE LIABLE FOR ANYDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGESOTHER THAN AS EXPRESSLY PROVIDED BY SPECIFICLAW. NO PERSON HAS THE AUTHORITY TO BINDCORDIS TO ANY REPRESENTATION OR WARRANTYEXCEPT AS SPECIFICALLY SET FORTH HEREIN.

Descriptions or specifications in Cordis printed matter,including this publication, are meant solely to generallydescribe the product at the time of manufacture and donot constitute any express warranties.

Cordis Corporation will not be responsible for any direct,incidental, or consequential damages resulting fromreuse of the product.

Protected under one or more of the following U.S. patents:5,843,244; 6,019,778; 6,129,755 and other patents pending theU.S. and other countries.

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Cordis Operations:

The Netherlands:Cordis Europa N.V.Oosteinde 8NL-9301 LJ RodenTelephone 050-5022222

USA:Cordis CorporationP.O. Box 025700Miami, FL 33102-5700Telephone 786-313-2000

EU Authorized Representative:Cordis Europa N.V.Oosteinde 8NL-9301 LJ RodenThe NetherlandsTelephone 050-5022222

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Cordis Sales / Marketing Offices:

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Canada:Johnson & Johnson Medical Products200 Whitehall DriveMarkham, OntarioCanada L3R 0T5Telephone 905-946-1611

European HQ:Johnson & Johnson Medical N.V./S.A.,Waterloo Office Park, Building HDrève Richelle 161B-1410 WaterlooBelgiumTelephone 02-352 14 11

France:Cordis S.A.S.1 Rue Camille DesmoulinsTSA 71001F-92787 Issy les Moulineaux Cedex 9Telephone 01 55 00 33 00

Germany:Cordis Medizinische Apparate GmbHElisabeth-Selbert-Straße 4aD-40764 LangenfeldTelefon 02173 205-0

Hong Kong:Johnson & Johnson Hong Kong, Ltd.Medical DivisionRoom 1816-1819, 18/FGrand Century Place, Tower 1193, Prince Edward Road WestMongkok, KowloonTelephone 2738 2818

Italy:Cordis Italia S.p.A.Via Chiese, 74I-20126 MilanoTelephone 02-64410.1

Japan:Cordis JapanJohnson & Johnson K.K.East 21 Tower 10th Floor6-3-2 Toyo, Koto-kuTokyo 135-0016Telephone 03-5632-7200

The Netherlands:Johnson & Johnson Medical BVPostbus 188NL-3800 AB AmersfoortTelephone 033-450 0729

Portugal:Johnson & Johnson ProdutosProfissionaisEstr. Consiglieri Pedroso N° 69-AQueluz de BaixoPT-2745-555 BarcarenaTelephone 800 200 246

Spain:Johnson & Johnson S.A.Paseo de las doce Estrellas, 5-7Campo de las NacionesE-28042 MadridTelephone 91 722 8000

Sweden:Johnson & Johnson ABStaffans väg 2SE-191 84 SollentunaTelephone 08-626 22 00

Switzerland:Johnson & Johnson AGCordis DivisionRotzenbühlstrasse 55CH-8957 SpreitenbachTelephone 056-417 3207

United Kingdom:Johnson & Johnson Medical Ltd.Coronation Road, South AscotBerkshire SL5 9EYTelephone 01344 871000

USA:Cordis CorporationP.O. Box 025700Miami, FL 33102-5700Telephone 786-313-2000

Cordis CorporationP.O. Box 4917Warren, NJ 07059-0917Telephone 908-755-8300

September 10368453-2

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